跳至主要内容
临床试验/NCT01117415
NCT01117415已完成不适用

Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Compare cost effectiveness data at one year postoperative

研究概览

简要总结

Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.

详细描述

The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidate of either sex
  • 18 years old or above
  • Have symptomatic cholelithiasis
  • Wish to undergo laparoscopic cholecystectomy for treatment

排除标准

  • Not Applicable

结局指标

主要结局

Compare cost effectiveness data at one year postoperative

时间窗: 1 year

One year cost effectiveness data comparing transgastric cholecystectomy, transvaginal cholecystectomy, and laparoscopic cholecystectomy. Costs from two national databases: the State Ambulatory Surgery Database (SASD) and the NIS. The main outcome measure for this study will be cost per quality adjusted life year (QALY). Markov modeling techniques for model patient experiences for each of the procedures analyzed. Monte Carlo simulation will be used to calculate cost per QALY over a one year time span with determination of the incremental cost effectiveness ratio.

次要结局

  • Analyze the important factor that contributes to cost effectiveness at one year post operative.(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Marks, MD

Principal Investigator

University Hospitals Cleveland Medical Center

研究点 (1)

Loading locations...

相似试验